Integrative Cognitive-Affective Therapy for Binge Eating Disorder

July 15, 2020 updated by: University of Minnesota
The purpose of the study is to test a newly developed individual psychotherapy treatment for binge eating disorder in adults. This treatment is a type of individual psychotherapy called Integrative Cognitive-Affective Therapy (ICAT) that focuses on helping people change their behaviors, feelings, thoughts about themselves, and relationships. This new treatment is being compared to an existing treatment called Cognitive-Behavior Therapy-Guided Self Help (CBTgsh), which focuses on changing behavior patterns through the use of reading and homework assignments along with sessions with a therapist. The primary hypothesis of this investigation is that ICAT will be associated with greater reductions in binge eating at end of treatment and follow-up compared to CBTgsh.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota
    • North Dakota
      • Fargo, North Dakota, United States, 58107
        • Neuropsychiatric Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Binge eating disorder (DSM-5)

Exclusion Criteria:

  • History of gastric bypass surgery
  • Medical condition acutely affecting eating and/or weight
  • Current medical and/or psychiatric instability (e.g., acute suicidality)
  • Psychosis and/or bipolar disorder
  • Severe cognitive impairment or developmental disability
  • Inability to read English
  • Current substance use disorder
  • Current participation in psychotherapy and/or commercial weight loss program
  • Change in dosage and/or frequency of psychotropic medication in the past 6 weeks
  • Pregnant or breast feeding
  • BMI < 21

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT-Guided Self Help
Integrative Cognitive-Affective Therapy CBT-Guided Self Help
Behavioral: CBT-Guided Self Help
CBT-Guided Self Help focuses on changing behavior patterns through the use of reading and homework assignments along with sessions with a therapist.
Experimental: Integrative Cognitive-Affective Therapy
Integrative Cognitive-Affective Therapy is a psychotherapy treatment for binge eating that focuses on changing behaviors, feelings, thoughts, and relationships
Behavioral: Integrative Cognitive-Affective Therapy
Integrative Cognitive-Affective Therapy is a psychotherapy treatment for binge eating that focuses on changing behaviors, feelings, thoughts, and relationships

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binge Eating Episode Frequency (Eating Disorder Examination)
Time Frame: 17 Weeks and 6-month Follow-up
Frequency of binge eating as measured by the Eating Disorder Examination
17 Weeks and 6-month Follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Eating Disorder Symptoms (EDE)
Time Frame: 17 Weeks and 6-month follow-up
Global Eating Disorder Symptoms as measured by the Eating Disorder Examination
17 Weeks and 6-month follow-up
Symptoms of Depression (BDI)
Time Frame: 17 Weeks and 6-month follow-up
Symptoms of Depression as measured by the Beck Depression Inventory
17 Weeks and 6-month follow-up
Symptoms of Anxiety (STAI)
Time Frame: 17 Weeks and 6-month Follow-up
Symptoms of Anxiety as measured by the State-Trait Anxiety Inventory
17 Weeks and 6-month Follow-up
Self-Esteem (RSEQ)
Time Frame: 17 Weeks and 6-month Follow-up
Self-esteem as measured by the Rosenberg Self-Esteem Questionnaire
17 Weeks and 6-month Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

Neuropsychiatric Research Institute, Fargo, North Dakota

Investigators

  • Principal Investigator: Carol B Peterson, PhD, University of Minnesota
  • Principal Investigator: Stephen A Wonderlich, PhD, Neuropsychiatric Research Institute/University of North Dakota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSYCH-2016-22310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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